Hearing Impairment, SensorineuralCRESTNCT03134989
Cochlear Response Telemetry and Hearing Preservation
A study testing Cochlear implant in people with Hearing Impairment, Sensorineural, run by Cochlear at 1 site in Argentina.
Trial summary
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Impairment, Sensorineural
- What is being tested?
- Cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteArgentina
- Study dates
- 22 Dec 2017to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
- 18 years of age or older at the time of enrolment
- Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
- Willingness to participate in and to comply with all requirements of the protocol
Who cannot join
- Prior cochlear implantation in the ear to be implanted
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Diagnosis of auditory neuropathy
- Active middle-ear infection
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.
- Conditions
- Hearing Impairment, Sensorineural
- Being tested
- Cochlear implant
- Keywords
- cochlear implantation, electrocochleography
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantDevice
Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant recipients | Other | Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery. Receives: Device: Cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 4 to 6 weeks following surgery and compared with average LF hearing thresholds measured relative to the pre-operative baseline measured within 90 days of CI surgery. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response?
Measured: Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery
Secondary outcomes (2)
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 3 months following cochlear implant activation and compared with average LF hearing thresholds measured preoperatively. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response.
Measured: Baseline (pre-operative) compared to 3 months post cochlear implant activation
Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected).
The onset of the cochlear microphonic (CM) response will be measured intraoperative to determine if there is a relationship between the onset of the CM response during electrode insertion and the preoperative high-frequency acoustic hearing thresholds. The onset of the CM response will be tracked by impedance measures that are interleaved with the CM recordings. As each electrode in the array enters the perilymph in the cochlea there will be a measured reduction in impedance. CM onset will be defined in terms of the nth electrode (out of the 22 electrodes) to enter the cochlea. Preoperative high-frequency hearing will be defined as the average of preoperative thresholds at frequencies of 2 kHz, 3 kHz and 4 kHz for each individual subject.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start22 Dec 2017
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Why it stopped: slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Impairment, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134989
- Sponsor's protocol ID
- CLTD5667
- Acronym
- CREST
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2017
- Last updated
- 24 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation
- ClinicalTrials.gov ID
- NCT03134989
- Acronym / sponsor ID
- CREST / CLTD5667
- Conditions
- Hearing Impairment, Sensorineural
- Keywords
- cochlear implantation, electrocochleography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrolment
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant recipients | Other | Device: Cochlear implantStudy group is comprised of cochlear implant patients already identified as candidates and undergoing surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
- 18 years of age or older at the time of enrolment
- Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
- Willingness to participate in and to comply with all requirements of the protocol
Key exclusion criteria (8 listed)
- Prior cochlear implantation in the ear to be implanted
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Diagnosis of auditory neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear implantStudy involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery | Device | Cochlear implant recipients |
Primary outcome
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Time frame: Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery
Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 4 to 6 weeks following surgery and compared with average LF hearing thresholds measured relative to the pre-operative baseline measured within 90 days of CI surgery. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response?
2 secondary outcomes
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Time frame: Baseline (pre-operative) compared to 3 months post cochlear implant activation
Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected).
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear implant in people with Hearing Impairment, Sensorineural, run by Cochlear at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively. (time frame: Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.